UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000034799
Receipt number R000039667
Scientific Title Surgical outcomes in patients who received presurgical treatment with pazopanib for advanced renal cell carcinoma with inferior vena cava tumor thrombus; a historical control study
Date of disclosure of the study information 2018/12/01
Last modified on 2020/09/10 08:46:15

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Basic information

Public title

Surgical outcomes in patients who received presurgical treatment with pazopanib for advanced renal cell carcinoma with inferior vena cava tumor thrombus; a historical control study

Acronym


Surgical outcomes in patients who received presurgical treatment with pazopanib for advanced renal cell carcinoma with inferior vena cava tumor thrombus; a historical control study

Scientific Title

Surgical outcomes in patients who received presurgical treatment with pazopanib for advanced renal cell carcinoma with inferior vena cava tumor thrombus; a historical control study

Scientific Title:Acronym


Surgical outcomes in patients who received presurgical treatment with pazopanib for advanced renal cell carcinoma with inferior vena cava tumor thrombus; a historical control study

Region

Japan


Condition

Condition

Renal cell carcinoma

Classification by specialty

Urology

Classification by malignancy

Malignancy

Genomic information

YES


Objectives

Narrative objectives1

We evaluate improvement of surgical outcome of resection both tumor and thrombus by presurgical treatment with pazopanib in patients with advanced renal cell carcinoma (RCC) with inferior vena cava tumor thrombus.

Basic objectives2

Safety

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

bleeding volume in surgery

Key secondary outcomes

-Improvement of surgical invasion: Outcome of change from surgical procedure expected before surgery to minimally invasive surgical procedure due to tumor reduction.
-Operation time
-Grade 3 or higher complications
-Reduction in the level of tumor embolism according to the classification of Mayo clinic
-Reduction rate of primary tumor and metastatic lesion.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

12 weeks oral administration of pazopanib.
Surgical excision of tumor and thrombus within 7 days and 21 days from the end date of pazopanib administration

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

1.Renal cell carcinoma with tumor thrombus
2.Tumor thrombus which reach Inferior vena cava
3.Written informed consent

Key exclusion criteria

1.Patients who did not participate in this study
2.Patients who participated in other clinical trials within 4 months.
3.Performance Status> 3
4.AST,ALT> 3.0*upper limit of normal range(ULN), or total Bil> 2.0*ULN
5.Patients who receive treatment of other cancer

Target sample size

25


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Tomoaki Terakawa

Organization

Kobe University Graduate School of Medicine

Division name

Urology

Zip code


Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN,

TEL

0783826155

Email

daatera0804@yahoo.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yasuyoshi Okamura

Organization

Kobe university Graduate School of Medicine

Division name

Urology

Zip code


Address

7-5-2 Kusunoki-cho, Chuo-ku, Kobe City, Hyogo Prefecture, JAPAN,

TEL

0783826155

Homepage URL


Email

dfgky008@gmail.com


Sponsor or person

Institute

Kobe university Graduate School of Medicine Division of Urology

Institute

Department

Personal name



Funding Source

Organization

Kobe university Graduate School of Medicine
Division of Urology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

神戸大学医学部付属病院


Other administrative information

Date of disclosure of the study information

2018 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled


Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2018 Year 11 Month 01 Day

Date of IRB

2019 Year 05 Month 24 Day

Anticipated trial start date

2018 Year 12 Month 01 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2018 Year 11 Month 07 Day

Last modified on

2020 Year 09 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039667


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name